Combined modality treatment systems, methods and apparatus for body contouring applications

ABSTRACT

Systems and methods that enable delivery of radiofrequency energy and cryotherapy applications to adipose tissue for reduction and contouring of body fat are described herein. Aspects of the disclosure are directed to methods for reducing surface irregularities in a surface of a subject&#39;s skin resulting from an uneven distribution of adipose tissue in the subcutaneous layer. The method can include delivering capacitively coupled or conductively coupled radiofrequency energy to a target region of the subject at a frequency which selectively heats fibrous septae in a subcutaneous layer of the target region to a maximum temperature less than a fibrous septae denaturation temperature. Furthermore, the method can include removing heat such that lipid-rich lobules in the subcutaneous layer are affected while non-lipid-rich cells and lipid-rich regions adjacent to the fibrous septae are not substantially affected.

INCORPORATION BY REFERENCE OF COMMONLY-OWNED APPLICATIONS

The following commonly assigned U.S. Patent Applications areincorporated herein by reference in their entirety:

U.S. patent application Ser. No. 11/750,953, filed on May 18, 2007,entitled “METHOD OF ENHANCED REMOVAL OF HEAT FROM SUBCUTANEOUSLIPID-RICH CELLS AND TREATMENT APPARATUS HAVING AN ACTUATOR”;

U.S. Pat. No. 6,032,675 entitled “FREEZING METHOD FOR CONTROLLED REMOVALOF FATTY TISSUE BY LIPOSUCTION”;

U.S. Patent Publication No. 2007/0255362 entitled “CRYOPROTECTANT FORUSE WITH A TREATMENT DEVICE FOR IMPROVED COOLING OF SUBCUTANEOUSLIPID-RICH CELLS”;

U.S. Patent Publication No. 2007/0198071 entitled “COOLING DEVICE FORREMOVING HEAT FROM SUBCUTANEOUS LIPID-RICH CELLS”;

U.S. Patent Publication No. 2008/0077201 entitled “COOLING DEVICES WITHFLEXIBLE SENSORS”;

U.S. Patent Publication No. 2008/0077211 entitled “COOLING DEVICE HAVINGA PLURALITY OF CONTROLLABLE COOLING ELEMENTS TO PROVIDE A PREDETERMINEDCOOLING PROFILE”;

U.S. patent application Ser. No. 11/933,066, filed Oct. 31, 2007,entitled “METHOD AND APPARATUS FOR COOLING SUBCUTANEOUS LIPID-RICH CELLSOR TISSUE,” now abandoned;

U.S. patent application Ser. No. 11/777,995, filed Jul. 13, 2007,entitled “LIMITING USE OF DISPOSABLE PATIENT PROTECTION DEVICES,” nowabandoned;

U.S. patent application Ser. No. 11/777,992, filed Jul. 13, 2007,entitled “SYSTEM FOR TREATING LIPID-RICH REGIONS,” now abandoned;

U.S. patent application Ser. No. 11/777,999, filed Jul. 13, 2007,entitled “MANAGING SYSTEM TEMPERATURE TO REMOVE HEAT FROM LIPID-RICHREGIONS,” now abandoned;

U.S. patent application Ser. No. 11/778,003, filed Jul. 13, 2007,entitled “SECURE SYSTEM FOR REMOVING HEAT FROM LIPID-RICH REGIONS,” nowabandoned;

U.S. patent application Ser. No. 11/778,001, entitled “USER INTERFACESFOR A SYSTEM THAT REMOVES HEAT FROM LIPID-RICH REGIONS,” filed Jul. 13,2007, now abandoned;

U.S. Patent Publication No. 2008/0077202 entitled “TISSUE TREATMENTMETHODS”; and

U.S. Provisional Patent Application Ser. No. 61/100,248, filed Sep. 25,2008, entitled “TREATMENT PLANNING SYSTEMS AND METHODS FOR BODYCONTOURING APPLICATIONS.”

TECHNICAL FIELD

The present application relates generally to combined modality treatmentapparatuses, systems and methods for body contouring applicationsincluding systems and methods for delivering radio frequency energy andcooling to affect subcutaneous lipid-rich cells.

BACKGROUND

Excess body fat, or adipose tissue, may be present in various locationsof the body, including, for example, the thigh, buttocks, abdomen,knees, back, face, arms, and other areas. Excess adipose tissue candetract from personal appearance and athletic performance. Moreover,excess adipose tissue is thought to magnify the unattractive appearanceof cellulite, which forms when subcutaneous fat lobules protrude orpenetrate into the dermis and create dimples where the skin is attachedto underlying structural fibrous strands. Cellulite and excessiveamounts of adipose tissue are often considered to be unappealing.Moreover, significant health risks may be associated with higher amountsof excess body fat.

A variety of methods have been used to treat individuals having excessbody fat and, in many instances, non-invasive removal of excesssubcutaneous adipose tissue can eliminate unnecessary recovery time anddiscomfort associated with invasive procedures such as liposuction.Conventional non-invasive treatments for removing excess body fattypically include topical agents, weight-loss drugs, regular exercise,dieting, or a combination of these treatments. One drawback of thesetreatments is that they may not be effective or even possible undercertain circumstances. For example, when a person is physically injuredor ill, regular exercise may not be an option. Similarly, weight-lossdrugs or topical agents are not an option when they cause an allergic ornegative reaction. Furthermore, fat loss in selective areas of aperson's body often cannot be achieved using general or systemicweight-loss methods.

Other methods designed to reduce subcutaneous adipose tissue includelaser-assisted liposuction and mesotherapy. Newer non-invasive methodsinclude applying radiant energy to subcutaneous lipid-rich cells via,e.g., radio frequency and/or light energy, such as described in U.S.Patent Publication No. 2006/0036300 and U.S. Pat. No. 5,143,063, or via,e.g., high intensity focused ultrasound (HIFU) radiation such asdescribed in U.S. Pat. Nos. 7,258,674 and 7,347,855. Additional methodsand devices for non-invasively reducing subcutaneous adipose tissue bycooling are disclosed in U.S. Pat. No. 7,367,341 entitled “METHODS ANDDEVICES FOR SELECTIVE DISRUPTION OF FATTY TISSUE BY CONTROLLED COOLING”to Anderson et al. and U.S. Patent Publication No. 2005/0251120 entitled“METHODS AND DEVICES FOR DETECTION AND CONTROL OF SELECTIVE DISRUPTIONOF FATTY TISSUE BY CONTROLLED COOLING” to Anderson et al., the entiredisclosures of which are incorporated herein by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not drawn to scale, and some of these elementsare arbitrarily enlarged and positioned to improve drawing legibility.Further, the particular shapes of the elements as drawn are not intendedto convey any information regarding the actual shape of the particularelements, and have been solely selected for ease of recognition in thedrawings.

FIG. 1 is an isometric view schematically illustrating a combinedmodality treatment system for treating subcutaneous lipid-rich regionsof a patient in accordance with an embodiment of the disclosure.

FIG. 2 is a schematic cross-sectional view of the skin and subcutaneoustissue of a subject.

FIG. 3 is a schematic cross-sectional view of the skin and subcutaneoustissue of a subject illustrating the application of RF current thereto.

FIG. 4 is a partial cross-sectional view illustrating a combinedmodality treatment device suitable to be used in the system of FIG. 1 inaccordance with embodiments of the disclosure.

FIG. 5 is a flow diagram illustrating a method for reducingirregularities in a surface of a subject's skin resulting from an unevendistribution of adipose tissue in the subcutaneous layer in accordancewith an embodiment of the disclosure.

FIG. 6 is a schematic block diagram illustrating computing systemsoftware modules and subcomponents of a computing device suitable to beused in the system of FIG. 1 in accordance with an embodiment of thedisclosure.

DETAILED DESCRIPTION A. Overview

Systems, devices and methods are provided herein that enablesimultaneous or sequential delivery of capacitively coupledradiofrequency (RF) energy and cooling to selectively affect targetedsubcutaneous lipid-rich cells. Several of the details set forth beloware provided to describe the following examples and methods in a mannersufficient to enable a person skilled in the relevant art to practice,make and use them. Several of the details and advantages describedbelow, however, may not be necessary to practice certain examples andmethods of the technology. Additionally, the technology may includeother examples and methods that are within the scope of the claims butare not described in detail.

Reference throughout this specification to “one example,” “an example,”“one embodiment,” or “an embodiment” means that a particular feature,structure, or characteristic described in connection with the example isincluded in at least one example of the present technology. Thus, theoccurrences of the phrases “in one example,” “in an example,” “oneembodiment,” or “an embodiment” in various places throughout thisspecification are not necessarily all referring to the same example.Furthermore, the particular features, structures, routines, stages, orcharacteristics may be combined in any suitable manner in one or moreexamples of the technology. The headings provided herein are forconvenience only and are not intended to limit or interpret the scope ormeaning of the claimed technology.

Some embodiments of the disclosure are directed to methods for reducingirregularities in a surface of a subject's skin resulting from an unevendistribution of adipose tissue in the subcutaneous layer. For example, amethod can include selectively heating tissue by one or more methods,such as, e.g., by delivering capacitively or conductively coupledradiofrequency (RF) energy to a target region of the subject at afrequency, duration and power. The delivered RF energy selectively heatsfibrous septae in a subcutaneous layer of the target region.Furthermore, the method can include removing heat such that lipid-richlobules in the subcutaneous layer at the target region are reduced innumber and/or size to an extent while non-lipid-rich cells andlipid-rich regions adjacent to the fibrous septae are not reduced innumber or size to the extent, thereby reducing irregularities in thesurface of skin of the subject.

Other embodiments of the disclosure are directed to a system fornon-invasive, transdermal removal of heat from subcutaneous lipid-richcells of a subject. The system can include a treatment unit in thermalcommunication with a fluid chamber, wherein the fluid chamber can houseand provide a coolant. The system can also include a radiofrequency (RF)energy generating unit for generating RF current, and a treatment devicein fluid communication with the treatment unit and in electricalcommunication with the RF energy generating unit. The system can furtherinclude a controller in communication with the treatment unit, the RFenergy generating unit and the treatment device. In one embodiment, thecontroller has instructions for causing the treatment device tocapacitively or conductively couple RF energy to the subject toselectively heat connective tissue in a target region beneath anepidermis of the subject to a maximum temperature less than a collagendenaturation temperature. The treatment device can be further configuredto reduce a temperature of the target region beneath the epidermis ofthe subject to selectively reduce the temperature of subcutaneouslipid-rich cells in the target region such that the subcutaneouslipid-rich cells are substantially affected while non-lipid rich cellsin the epidermis and subcutaneous lipid-rich cells adjacent to theconnective tissue are not substantially affected (e.g., damaged,injured, disrupted or destroyed).

Other aspects of the disclosure are directed toward a combined modalitytreatment system for selectively removing heat from subcutaneouslipid-rich cells in a target region of a subject having skin. Thecombined modality treatment system can include treatment unit in thermalcommunication with a fluid chamber, wherein the fluid chamber can houseand provide a coolant. The combined modality treatment system can alsoinclude a RF energy source for generating RF current. Further, thesystem can include a controller and a treatment device. The treatmentdevice can include a heat exchange plate coupled to the RF energy sourceand a thermoelectric cooling element in communication with the treatmentunit. In one embodiment, the controller includes instructions that causethe treatment device to capacitively or conductively coupleradiofrequency (RF) energy to the skin of the subject to selectivelyheat fibrous septae in the target region to a final temperature lessthan a fibrous septae denaturation temperature. The controller can alsoinclude instructions that cause the treatment device to remove heat fromthe subcutaneous lipid-rich cells of the subject during a treatmentprocess such that subcutaneous lipid-rich cells are substantiallyaffected while non-lipid-rich cells and subcutaneous lipid-rich cellsadjacent to the fibrous septae are not substantially affected.

B. Combined Modality Treatment System

FIG. 1 and the following discussion provide a brief, general descriptionof an example of a combined modality treatment system 100 in whichaspects of the disclosure can be implemented. Those skilled in therelevant art will appreciate that other examples of the disclosure canbe practiced with other treatment systems and treatment protocols,including invasive, minimally invasive, other non-invasive medicaltreatment systems, and/or combinations of one or more of the above fortreating a patient. In general, the term “treatment system”, as usedgenerally herein, refers to any of the above system categories ofmedical treatment as well as any treatment regimes or medical deviceusage.

In one embodiment, the combined modality treatment system 100 issuitable for treating a subject's subcutaneous adipose tissue, includingsuch as by cooling. The term “subcutaneous tissue” means tissue lyingbeneath the dermis and includes subcutaneous fat, or adipose tissue,which primarily is composed of lipid-rich cells, or adipocytes. Whencooling the subcutaneous tissues to a temperature lower than 37° C.,subcutaneous lipid-rich cells can selectively be affected. In general,the epidermis and dermis of the patient 101 have lower amounts of lipidscompared to the underlying lipid-rich cells forming the subcutaneoustissues. Because non-lipid-rich cells usually can withstand coldertemperatures better than lipid-rich cells, the subcutaneous lipid-richcells can selectively be affected while maintaining the integrity of thenon-lipid-rich cells in the dermis and epidermis. In some embodiments,the treatment system 100 can apply cooling temperatures to the skin ofthe patient in a range of from about −20° C. to about 20° C. In otherembodiments, the cooling temperatures can be from about −20° C. to about10° C., from about −15° C. to about 5° C., or from about −10° C. toabout 0° C.

Without being bound by theory, the selective effect of cooling onlipid-rich cells is believed to result in, for example, membranedisruption, shrinkage, disabling, destroying, removing, killing, oranother method of lipid-rich cell alteration. Such alteration isbelieved to be an intermediate and/or final result of one or moremechanisms acting alone or in combination. It is thought that suchmechanism or mechanisms trigger an apoptotic cascade, which is believedto be the dominant form of lipid-rich cell death by non-invasivecooling.

Apoptosis, also referred to as “programmed cell death”, is agenetically-induced death mechanism by which cells self-destruct withoutincurring damage to surrounding tissues. An ordered series ofbiochemical events induce cells to morphologically change. These changesinclude cellular blebbing, loss of cell membrane asymmetry andattachment, cell shrinkage, chromatin condensation, and chromosomal DNAfragmentation. Injury via an external stimulus, such as cold exposure,is one mechanism that can induce apoptosis in cells. Nagle, W. A.,Soloff, B. L., Moss, A. J. Jr., Henle, K. J. “Cultured Chinese HamsterCells Undergo Apoptosis After Exposure to Cold but NonfreezingTemperatures” Cryobiology 27, 439-451 (1990).

One aspect of apoptosis, in contrast to cellular necrosis (a traumaticform of cell death causing local inflammation), is that apoptotic cellsexpress and display phagocytic markers on the surface of the cellmembrane, thus marking the cells for phagocytosis by, for example,macrophages. As a result, phagocytes can engulf and remove the dyingcells (e.g., the lipid-rich cells) without eliciting an immune response.Temperature exposures that elicit these apoptotic events in lipid-richcells may contribute to long-lasting and/or permanent reduction andreshaping of subcutaneous adipose tissue.

Without being bound by theory, one mechanism of apoptotic lipid-richcell death by cooling is believed to involve localized crystallizationof lipids within the adipocytes at temperatures that do not inducecrystallization in non-lipid-rich cells. The crystallized lipids mayselectively injure these cells, inducing apoptosis (and may also inducenecrotic death if the crystallized lipids damage or rupture the bilayerlipid membrane of the adipocyte). Another mechanism of injury involvesthe lipid phase transition of those lipids within the cell's bilayerlipid membrane, which results in membrane disruption, thereby inducingapoptosis. This mechanism is well documented for many cell types and maybe active when adipocytes, or lipid-rich cells, are cooled. Mazur, P.,“Cryobiology: the Freezing of Biological Systems” Science, 68: 939-949(1970); Quinn, P. J., “A Lipid Phase Separation Model of Low TemperatureDamage to Biological Membranes” Cryobiology, 22: 128-147 (1985);Rubinsky, B., “Principles of Low Temperature Preservation” Heart FailureReviews, 8, 277-284 (2003). Other yet-to-be understood apoptoticmechanisms may exist, based on the relative sensitivity of lipid-richcells to cooling compared to non-lipid rich cells.

In addition to the apoptotic mechanisms involved in lipid-rich celldeath, local cold exposure may induce lipolysis (i.e., fat metabolism)of lipid-rich cells. For example, cold stress has been shown to enhancerates of lipolysis from that observed under normal conditions whichserves to further increase the volumetric reduction of subcutaneouslipid-rich cells. Vallerand, A. L., Zamecnik. J., Jones, P. J. H.,Jacobs, I. “Cold Stress Increases Lipolysis, FFA Ra and TG/FFA Cyclingin Humans” Aviation, Space and Environmental Medicine 70, 42-50 (1999).

Cellulite (Gynoid lipodystrophy) typically is a hormonally mediatedcondition characterized by the uneven distribution of adipose tissue inthe subcutaneous layer that gives rise to an irregular, dimpled skinsurface common in women. Cellulite-prone tissue can be characterized bythe uneven thickness and distribution of some fibrous septae strands.Piérard, G. E., Nizet, J. L, Piérard-Franchimont, C., “Cellulite: FromStanding Fat Herniation to Hypodermal Stretch Marks,” Am. J. Dermatol.22:1, 34-37 (2000). Cellulite has proved to be a difficult and vexingproblem to treat, although the demand for an effective treatment hasbeen and remains quite high.

As shown schematically in FIG. 2, adipose tissue is subdivided into fatcell chambers or lobules (also called “papillae adiposae”) 201 byconnective collagenous tissue called fibrous septae 202. The fibrousseptae 202, which for females tend to generally be orientedperpendicular to the skin surface and anchor the dermal layers 203 tothe underlying fascia and muscle (not shown), are organized within thesubcutaneous layer to form a connective web around the adipose cells orfat lobules 202. Subcutaneous adipose cells and their lobules. 202 arenot uniformly distributed throughout the subcutaneous tissue layer(e.g., between the dermis and the muscle layers), but exhibit regionaldifferences in size and shape. These regional differences can, in part,be due to gender, age, genetics, hormones and physical conditioningamong other physiological factors. The number, size, distribution andorientation of fibrous septae 202 also vary by body location, gender andage. For example, as described above, histological studies have shownthat fibrous septae architecture in females differs from that in males.

In males, fibrous septae 202 tend to form an intersecting network thatdivide the papillae adiposae into small, polygonal units. In contrast,fibrous septae 202 in some females may tend to be orientedperpendicularly to the cutaneous surface, creating fat cell chambersthat are columnar in shape and sequestered by the connective strands andthe overlaying dermis layer 203 (see, e.g., FIG. 2). When theintersecting fibrous septae 202 are more uniform in size and elasticityas is characteristic of males, the forces within and between the fibrousseptae and their surrounding tissue tend to be distributed relativelyevenly. However, the columnar architecture of the fibrous septae 202found in some females can result in an uneven distribution of forcesthroughout the subcutaneous tissue. In particular, and without beingbound by theory, it is believed that this uneven distribution of forcesis partially manifested by the columnar fibrous septae 202 being held ina state of tension by the underlying fascia and other tissue, resultingin a tethering or anchoring effect at the point where each such septum202 connects with the dermal tissue 203. This tethering or anchoring isin turn manifested at the skin surface as a low spot 204 relative toadjacent dermal tissue 203 not directly above such septae, which tendsto herniate as the papillae adiposae bulge into the dermal tissue 203.When viewed over a larger scale of a few square centimeters, thenon-homogeneous nature of the skin surface's relative high and lowpoints results in a dimpled or irregular appearance characteristic ofcellulite.

As described above, cooling the subcutaneous tissues to a temperaturelower than 37° C. selectively can affect lipid-rich cells. Cooling thelipid-rich cells of the subcutaneous layer tends uniformly to affect theadipose cells distributed throughout the subcutaneous tissue at a givendepth below the dermis, for instance, when such lipid-rich cells arecooled non-invasively. As with the epidermal and dermal layers of thepatient 101, however, the fibrous septae 202 generally are not affectedby such treatment temperatures. To selectively treat the bulging orherniating adipose cells near the dermal—subcutaneous interfaceassociated with cellulite conditions, the combined modality treatmentsystem 100 can further be configured to selectively remove heat from(i.e., cool) the bulging and/or herniating fat lobules near the dermallayer and distal from the tethering fibrous septae 202, while limitingthe disruption of adipose tissue near the septae, which lie near the lowspots. Such selective disruption of the fat lobules 201 that constitutethe high spots will have the general effect of flattening the overallcontour of the skin.

Accordingly, in one embodiment, the combined modality treatment system100 is configured to not only cool subcutaneous tissue as describedherein but also to selectively heat tissue such as the fibrous septae202 and certain adipose tissue according to the methods describedherein. One method of selectively heating such tissue is by the deliveryof radiofrequency (RF) energy, including for example capacitivelycoupled RF energy, such as a low-level monopolar RF energy as well asconductively coupled RF energy, to the subcutaneous tissue selectivelyto heat regions of tissue bound by the connective web of fibrous septae.Adipose cells are composed almost entirely of lipids, which generallyhave low thermal and electrical conductivities relative to other tissue.In contrast, fibrous septae have similar properties to the dermis and,for example, have been shown to conduct electrical energy moreefficiently. Due to this high electrical and thermal conductivity offibrous septae relative to lipids in adipose cells, the connectivestrands can provide a path of least resistance for capacitively orinductively coupled RF current traveling via, e.g., the surface of theskin through the epidermis and dermis, and around subcutaneous adiposetissue RF current, (which is high frequency current in the frequencyrange of about 0.3 MHz to about 100 MHz or higher, or in someembodiments in the range of about 0.3 MHz to about 40 MHz, while inother embodiments in the range of about 0.3 MHz to about 6 MHz),produces a thermal effect on living tissue depending on the electricalproperties of the tissue. Other methods of applying energy toselectively heat tissue as described herein may be used in addition toor in place of RF energy, including, e.g., optical (e.g., laser light),acoustic (e.g., ultrasound), infrared, microwave, etc.

A schematic depiction of the application of energy such as RF current210 to a region of dimpled tissue near a fibrous septum 202 is shown inFIG. 3. As RF current 210 is applied via an electrode as describedherein, the current 210 concentrates in the dermal and connective tissuesuch as the fibrous septum 202 as described above. Heating generated byapplication of this RF current, depicted by arrows 210, heats thefibrous septum 202 and selected of the adipose cells in the fat lobules201 adjacent the fibrous septum 202. In the combined modality therapyassociated with the embodiments described herein, the treatmentparameters may be adjusted selectively to affect, in connection withcooling the subcutaneous tissue, the temperature profile of and thenumber of the adipose cells in the lobules 201 that are heated via theapplication of such RF current. For example, RF power in the range ofabout 0.02 to about 10 W/cm² or higher during cooling can have thedesired effect of warming the affected fibrous septae 202 and the fatlobules in a region near the affected fibrous septae 202 while allowingthe cooling and subsequent selective reduction of fat lobules 201 moredistal from the fibrous septae 202.

Heat is generated by the tissue's natural resistance to the flow ofcurrent (e.g., movement of electrons and ions) within an electricalfield as a reaction to the rapid change of polarity. This electricalfield changes polarity at a desired rate (e.g., at approximately 0.3 toapproximately 100 MHz), and the charged particles within the electricfield change orientation at that same frequency. The tissue's naturalresistance to the movement of these charged ions and molecules in theskin and subcutaneous tissue generates heat. Pope, K., Levinson, M.,Ross, E. V., “Selective Fibrous Septae Heating: An Additional Mechanismof Action for Capacitively Coupled Monopolar Radiofrequency,” Thermage,Inc. (2005).

In accordance with one embodiment, RF energy is generated and applied toa target region of the patient 101 while simultaneously cooling thesubcutaneous tissues to a temperature lower than 37° C. in a manner that(a) selectively heats the fibrous septae and the adipose tissue adjacentto the fibrous septae, and (b) selectively affects the lipid-rich cellsin regions of thinning or absent fibrous septae. In some embodiments,the fibrous septae are heated to a maximum temperature less than afibrous septae denaturation temperature. Thermal energy is known todenature collagenous tissue, such as fibrous septae, at temperatures ofapproximately 65° C. (e.g., between 60° C. and 80° C.). Therefore, inone embodiment, the capacitively coupled RF energy is delivered to thetarget region of the patient such that the fibrous septae are heated toa temperature approximately less than 60° C.

In some embodiments, the treatment system 100 can apply RF current tothe skin of the patient while/during cooling treatment in a simultaneousmanner, or in a sequential manner, such that the fibrous septae arewarmed to a range of from about 0° C. to about 60° C. In otherembodiments, the fibrous septae can be warmed to temperatures from about10° C. to about 30° C., from 5° C. to about 20° C., or from about 0° C.to about 10° C. For example, capacitively coupled RF energy can bedelivered to the target region of the patient 101 such that thelipid-rich cells adjacent to the fibrous septae are not cooled totemperatures below approximately 10° C.-15° C., while allowing thelipid-rich cells remote from the fibrous septae or near thinning fibrousseptae strands to cool to a temperature below approximately 10° C.

In some embodiments, RF energy can be applied to the target region ofthe patient 101 simultaneously with cooling (i.e., removing heat) suchthat a controllable temperature difference is maintained between (a) thefibrous septae and tissue adjacent to the fibrous septae, and (b)bulging or herniating adipose tissue spaced apart or otherwise separatedfrom the fibrous septae. In other embodiments, the RF energy can beapplied to the target region before, periodically during, or aftercooling for selectively affecting bulging or herniating adipose tissuein the subcutaneous layer of the patient 101.

In various embodiments, the combined modality treatment system 100includes a controller, a computing device, a data acquisition device, atreatment unit, an RF energy generating unit and one or moreapplicators. The system 100 can employ these components in variousembodiments to receive a selection of a treatment profile and apply theselected treatment using an applicator.

FIG. 1 is an isometric view schematically illustrating a combinedmodality treatment system 100 for selectively heating fibrous septae andremoving heat from herniated and/or bulging subcutaneous lipid-richregions of a subject patient 101 in accordance with an embodiment of thedisclosure. The system 100 can include a combined modality device 104including an applicator 105 that engages a target region of the subject101, such as the abdominal region 102. It will be understood thatcombined modality devices 104 and applicators 105 can be provided havingvarious shapes and sizes suitable for different body regions and bodyparts such that any suitable area for removing heat from a subcutaneouslipid-rich region of the subject 101 can be achieved.

An applicator, such as applicator 105, is a component of the system 100that both cools subcutaneous tissue and selectively heats subcutaneousfibrous septae in a region of a subject 101, such as a human or animal(i.e., “patient”). Various types of applicators may be applied duringtreatment, such as a vacuum applicator, a belt applicator (either ofwhich may be used in combination with a massage or vibratingcapability), and so forth. Each applicator may be designed to treatidentified portions of the patient's body, such as chin, cheeks, arms,pectoral areas, thighs, calves, buttocks, abdomen, “love handles”, back,and so forth. For example, the vacuum applicator may be applied at theback region, and the belt applicator can be applied around the thighregion, either with or without massage or vibration. Exemplaryapplicators and their configurations usable or adaptable for use withthe combined modality treatment system 100 variously are described in,e.g., commonly assigned U.S. Patent Publication Nos. 2007/0198071,2008/0077201, and 2008/0077211 and in U.S. patent application Ser. No.11/750,953. In further embodiments, the system 100 may also include apatient protection device (not shown) incorporated into or configuredfor use with the applicator that prevents the applicator from directlycontacting a patient's skin and thereby reducing the likelihood ofcross-contamination between patients, minimizing cleaning requirementsfor the applicator. The patient protection device may also include orincorporate various storage, computing, and communications devices, suchas a radio frequency identification (RFID) component, allowing forexample, use to be monitored and/or metered. Exemplary patientprotection devices are described in commonly assigned U.S. PatentPublication No. 2008/0077201.

In the present example, the system 100 can also include a treatment unit106 and supply and return fluid lines 108 a-b between the combinedmodality treatment device 104 and the treatment unit 106. A treatmentunit 106 is a device that, based on variable power input, can increaseor decrease the temperature at a connected combined modality treatmentdevice 104 that in turn may be attached to or incorporated into theapplicator 105. The treatment unit 106 can remove heat from acirculating coolant to a heat sink and provide a chilled coolant to thecombined modality treatment device 104 via the fluid lines 108 a-b.Alternatively, treatment unit 106 can circulate warm coolant to thecombined modality treatment device 104 during periods of warming.Examples of the circulating coolant include water, glycol, syntheticheat transfer fluid, oil, a refrigerant, and/or any other suitable heatconducting fluid. The fluid lines 108 a-b can be hoses or other conduitsconstructed from polyethylene, polyvinyl chloride, polyurethane, and/orother materials that can accommodate the particular circulating coolant.The treatment unit 106 can be a refrigeration unit, a cooling tower, athermoelectric chiller, or any other device capable of removing heatfrom a coolant. Alternatively, a municipal water supply (e.g., tapwater) can be used in place of the treatment unit 106. One skilled inthe art will recognize that there are a number of other coolingtechnologies that could be used such that the treatment unit or chillerneed not be limited to those described herein.

The system 100 can further include an RF energy generating unit 107 andRF power lines 109 a-b between the treatment device 104, an RF currentreturn electrode (not shown) and the RF energy generating unit 107. TheRF energy generating unit 107 can include a variable powered RFgenerator capable of generating and delivering RF energy through the RFpower line 109 a to one or more RF electrodes, or other electricallyconductive material that can be charged with RF current, in the combinedmodality treatment device 104 for capacitively coupling radiofrequency(RF) energy to the target region of the subject 101. One advantage amongseveral of a system using capacitively coupled RF energy in the variousembodiments described herein is the ability to reduce or eliminateelectrode edge effects. In particular, and as described below, adielectric layer or film may be used on the one or more RF electrodes toincrease the impedance of the electrode and produce a more uniformcurrent flow through the electrode to the skin of the patient. Such alayer or film creates a capacitance effect whose magnitude and otherqualities may be controlled by the composition, surface area andthickness of the layer, the choice of methods by which the layer or filmis deposited and/or adhered to the RF electrode, and the frequency ofthe RF signal.

Alternatively, system 100 can be configured to conductively couple RFenergy to a patient. This may be accomplished by, e.g., the use of an RFelectrode without a dielectric layer or film. The choice of whether touse a capacitively coupled RF system or a conductively-coupled RF systemmay be predicated upon the particular design of the electrode, thelocation on the patient which the system 100 is used, frequency andpower settings, temperatures, treatment duration, and other suchparameters and other considerations.

In this example, the combined modality treatment device 104 includes atleast one applicator 105 and is associated with at least one treatmentunit 106. The applicator 105 can provide mechanical energy to create avibratory, massage, and/or pulsatile effect. The applicator 105 caninclude one or more actuators, such as, motors with eccentric weight, orother vibratory motors such as hydraulic motors, electric motors,pneumatic motors, solenoids, other mechanical motors, piezoelectricshakers, and so on, to provide vibratory energy or other mechanicalenergy to the treatment site. Further examples include a plurality ofactuators for use in connection with a single combined modalitytreatment device 104 and/or applicator 105 in any desired combination.For example, an eccentric weight actuator can be associated with onecombined modality treatment device 104 or applicator 105, while apneumatic motor can be associated with another section of the sametreatment device or applicator. This, for example, would give theoperator of the treatment system 100 options for differential treatmentof lipid rich cells within a single region or among multiple regions ofthe subject 101. The use of one or more actuators and actuator types invarious combinations and configurations with a combined modalitytreatment device 104 or applicator 105 may be possible.

The combined modality treatment device 104 can include one or more heatexchanging units. The heat exchanging unit can be a Peltier-typethermoelectric element, and the combined modality treatment device 104can have multiple individually controlled heat exchanging units (e.g.,between 1 and 50, between 10 and 45; between 15 and 21, approximately100, etc.) to create a custom spatial cooling profile and/or atime-varying cooling profile. Each custom treatment profile can includeone or more segments, and each segment can include a specified duration,a target temperature, and control parameters for features such asvibration, massage, vacuum, and other treatment modes. Treatment deviceshaving multiple individually controlled heat exchanging units aredescribed in commonly assigned U.S. Patent Publication No. 2008/0077211,U.S. Provisional Application No. 61/298,175, filed Jan. 25, 2010, andU.S. Provisional Application No. 61/354,615 filed Jun. 14, 2010.

Additionally, the combined modality treatment device 104 can include oneor more RF electrodes. For example, the RF electrodes can be a singleelectrode or a plurality of electrodes positioned in a desired orsegmented arrangement and can form a segmented flexible circuit. Inanother embodiment, the treatment device 104 can include an electricallyconductive material, such as aluminum, that can be charged with RFcurrent. RF power can be delivered to the RF electrodes via RF powerline 109 a and, thereafter, coupled to the target region of the subject101 to achieve selective heating of the underlying fibrous septaecollagen network and adjacent adipose tissue. Generally, RF electrodescan be monopolar or bipolar. Capacitively coupled monopolar RF currentflows from the electrode into the epidermis and dermis, through thesubcutaneous tissue via conduction along the less-resistant fibrousseptae and into the muscle tissue (at which location it ideally hasdissipated to a level that it does not have any appreciable effectthereon). The RF current continues to flow through the body to a returnelectrode (not shown) adhered to a second site on the patient and thenreturns to the RF energy generating unit 107 via line 109 b.

Alternatively, the treatment device 104 may operate without a returnelectrode and line 109 b. The return RF current flows out of the bodyand through the air to the RF energy generating unit 107 to complete thecircuit. The frequency in such a configuration, sometimes referred to a“unipolar” configuration, can be between about 30 MHz and about 50 MHz.In another embodiment, the frequency for such a configuration is betweenabout 35 MHz and about 45 MHz. In yet another embodiment, the frequencyfor such a configuration is about 40 MHz.

The system 100 can further include a power supply 110 and a controller114 operatively coupled to the combined modality treatment device 104and the applicator 105. In one embodiment, the power supply 110 canprovide a direct current voltage to the thermoelectric treatment device104 and/or the applicator 105 to remove heat from the subject 101. Thecontroller 114 can monitor process parameters via sensors (not shown)placed proximate to the combined modality treatment device 104 via acontrol line 116 to, among other things, adjust the heat removal rateand/or RF energy delivery rate based on the process parameters. Thecontroller 114 can further monitor process parameters to adjust theapplicator 105 based on treatment parameters, such as treatmentparameters defined in a custom treatment profile or patient-specifictreatment plan.

The controller 114 can exchange data with the applicator 105 via anelectrical line 112 or, alternatively, via a wireless or an opticalcommunication link. Note that control line 116 and electrical line 11.2are shown in FIG. 1 without any support structure. Alternatively,control line 116 and electrical line 112 (and other lines including, butnot limited to fluid lines 108 a-b and RF power lines 109 a-b) may bebundled into or otherwise accompanied by a conduit or the like toprotect such lines, enhance ergonomic comfort, minimize unwanted motion(and thus potential inefficient removal of heat from and/or delivery ofRF energy to subject 101), and to provide an aesthetic appearance tosystem 100. Examples of such a conduit include a flexible polymeric,fabric, or composite sheath, an adjustable arm, etc. Such a conduit (notshown) may be designed (via adjustable joints, etc.) to “set” theconduit in place for the treatment of subject 101.

The controller 114 can include any processor, Programmable LogicController, Distributed Control System, secure processor, and the like.A secure processor can be implemented as an integrated circuit withaccess-controlled physical interfaces; tamper resistant containment;means of detecting and responding to physical tampering; secure storage;and shielded execution of computer-executable instructions. Some secureprocessors also provide cryptographic accelerator circuitry. Securestorage may also be implemented as a secure flash memory, secure serialEEPROM, secure field programmable gate array, or secureapplication-specific integrated circuit.

In another aspect, the controller 114 can receive data from an inputdevice 118 (shown as a touch screen), transmit data to an output device120, and/or exchange data with a control panel (not shown). The inputdevice 118 can include a keyboard, a mouse, a stylus, a touch screen, apush button, a switch, a potentiometer, a scanner, or any other devicesuitable for accepting user input. The output device 120 can include adisplay or touch screen, a printer, video monitor, a medium reader, anaudio device, any combination thereof, and any other device or devicessuitable for providing user feedback.

In the embodiment of FIG. 1, the output device 120 is a touch screenthat functions as both an input device 118 and an output device 120. Thecontrol panel can include visual indicator devices or controls (e.g.,indicator lights, numerical displays, etc.) and/or audio indicatordevices or controls. The control panel may be a component separate fromthe input device 118 and/or output device 120, may be integrated withone or more of the devices, may be partially integrated with one or moreof the devices, may be in another location, and so on. In alternativeexamples, the control panel, input device 118, output device 120, orparts thereof (described herein) may be contained in, attached to, orintegrated with the combined modality treatment device 104 and/orapplicator 105. In this example, the controller 114, power supply 110,control panel, treatment unit 106, input device 118, and output device120 are carried by a rack 124 with wheels 126 for portability. Inalternative embodiments, the controller 114 can be contained in,attached to, or integrated with the combined modality treatment device104 and/or the applicator 105 and/or the patient protection devicedescribed above. In yet other embodiments, the various components can befixedly installed at a treatment site. Further details with respect tocomponents and/or operation of combined modality treatment device 104,treatment unit 106, applicator 105 and other components may be found incommonly-assigned U.S. patent application Ser. No. 11/750,953.

In operation, and upon receiving input to start a treatment protocol,the controller 114 can cause the applicator 105 to cycle through eachsegment of a prescribed treatment plan. In so doing, the applicator 105applies power to one or more combined modality treatment devices 104,such as thermoelectric coolers (e.g., TEC “zones”), to begin a coolingcycle and, for example, activate features or modes such as vibration,massage, vacuum, etc. Additionally, the RF energy generating unit 107 isused to generate and transfer RF energy to the RF electrodes in the oneor more combined modality treatment devices 104 to begin selectivelyheating the fibrous septae in the subcutaneous tissue in the targetregion of the subject 101.

Using temperature sensors (not shown) proximate to the one or morecombined modality treatment devices 104, the patient's skin, a patientprotection device, or other locations or combinations thereof, thecontroller 114 determines whether a temperature or heat flux is at asufficient temperature close to the target temperature or heat flux. Itwill be appreciated that while a region of the body (e.g., adiposetissue) has been cooled or heated to the target temperature, inactuality that region of the body may be close but not equal to thetarget temperature, e.g., because of the body's natural heating andcooling variations. Thus, although the system may attempt to heat orcool the tissue to the target temperature or to provide by a target heatflux, a sensor may measure a sufficiently close temperature. If thetarget temperature has not been reached, power can be increased ordecreased to change heat flux to maintain the target temperature or“set-point” to selectively affect bulging or herniating adipose lobulesat or near the interface between the dermis and subcutaneous tissue, orto affect adipose tissue spaced apart from anchoring fibrous septae inthe subcutaneous layer.

When the prescribed segment duration expires, the controller 114 mayapply the temperature and duration indicated in the next treatmentprofile segment. In some embodiments, temperature can be controlledusing a variable other than, or in addition to, power.

In some embodiments, heat flux measurements can indicate other changesor anomalies that can occur during treatment administration. Forexample, an increase in temperature detected by a heat flux sensor canindicate a freezing event at the skin or underlying tissue (i.e., dermaltissue). An increase in temperature as detected by the heat flux sensorscan also indicate movement associated with the applicator, causing theapplicator to contact a warmer area of the skin, for example. Methodsand systems for collection of feedback data and monitoring oftemperature measurements are described in commonly assigned U.S. patentapplication Ser. No. 12/196,246, entitled “MONITORING THE COOLING OFSUBCUTANEOUS LIPID-RICH CELLS, SUCH AS THE COOLING OF ADIPOSE TISSUE,”filed on Aug. 21, 2008, which is incorporated herein in its entirety byreference.

The combined modality treatment devices 104 may also include additionalsensors to detect process treatment feedback. For example, thermalsensors can be included on the combined modality treatment device 104and/or the RF energy generating unit 107 to measure voltage and currentthat is delivered to the target region of the subject 101. Thermalsensor output can be used, by the controller 114 for example, to controlthe delivery of RF power to the RF electrodes, the temperature of theelectrodes or the desired temperature of the fibrous septae tissueduring a treatment session. Additional sensors may be included formeasuring tissue impedance, treatment application force, tissue contactwith the applicator and RF energy interaction with the skin of thesubject 101 among other process parameters.

In one embodiment, feedback data associated with RF energy delivery andheat removal from lipid-rich lobules in the subcutaneous layer can becollected in real-time. Real-time collection and processing of suchfeedback data can be used in concert with treatment administration toensure that the process parameters used to reduce irregularities in asurface of subject's skin and adipose tissue are administered correctlyand efficaciously.

Although a noninvasive applicator is illustrated and discussed herein,minimally invasive applicators may also be employed. In such a case, theapplicator and patient protection device may be integrated. As anexample, a cryoprobe that may be inserted directly into the subcutaneousadipose tissue to cool or freeze the tissue is an example of such aminimally invasive applicator. Cryoprobes manufactured by, e.g.,Endocare, Inc., of Irvine, Calif. are suitable for such applications.This patent application incorporates by reference U.S. Pat. No.6,494,844, entitled “DEVICE FOR BIOPSY AND TREATMENT OF BREAST TUMORS”;U.S. Pat. No. 6,551,255, entitled “DEVICE FOR BIOPSY OF TUMORS”; U.S.Publication No. 2007-0055173, entitled “ROTATIONAL CORE BIOPSY DEVICEWITH LIQUID CRYOGEN ADHESION PROBE”; U.S. Pat. No. 6,789,545, entitled“METHOD AND SYSTEM FOR CRYOABLATING FIBROADENOMAS”; U.S. Publication No.2004-0215294, entitled “CRYOTHERAPY PROBE”; U.S. Pat. No. 7,083,612,entitled “CRYOTHERAPY SYSTEM”; and U.S. Publication No. 2005-0261753,entitled “METHODS AND SYSTEMS FOR CRYOGENIC COOLING”.

According to examples of the system 100, the applicator 105 and thecombined modality treatment device 104 combine to enhance disruption ofcooled adipose tissue while preserving warmed adipose tissue adjacentfibrous septae strands. Further, the examples can provide reducedtreatment time, reduced discomfort to the patient, and increasedefficacy of treatment.

Examples of the system may provide the combined modality treatmentdevice 104 and the applicator 105 which damage, injure, disrupt orotherwise reduce subcutaneous lipid-rich cells contributing to cellulitegenerally without collateral damage to non-lipid-rich cells orlipid-rich cells adjacent to selectively heated fibrous septae in thetreatment region. In general, it is believed that lipid-rich cells canselectively be affected (e.g., damaged, injured, or disrupted) byexposing such cells to low temperatures that do not so affectnon-lipid-rich cells. Moreover, as discussed above, RF energy can beadministered simultaneously and/or in consecutive fashion to selectivelyheat (e.g., warm) fibrous septae in the treatment region so as to warmadjacent adipose tissue. As a result, lipid-rich cells, such assubcutaneous adipose tissue that is bulging and/or herniating into thedermis layer, can be damaged while other cells in the same region aregenerally not damaged even though the non-lipid-rich cells at thesurface may be subject to even lower temperatures. The mechanical energyprovided by the applicator may further enhance the effect on lipid-richcells by mechanically disrupting the affected lipid-rich cells.

In some examples of the system 100, a cryoprotectant is used with thetreatment device to, among other advantages, assist in preventingfreezing of non lipid-rich tissue (e.g., dermal tissue) during treatmentas is described in commonly-assigned U.S. Patent Publication No.2007/0255362.

In one mode of operation, the applicator 105 is coupled to a combinedmodality treatment device 104. The treatment device may be configured tobe a handheld device such as the device disclosed in commonly-assignedU.S. patent application Ser. No. 11/359,092, filed on Feb. 22, 2006,entitled COOLING DEVICE FOR REMOVING HEAT FROM SUBCUTANEOUS LIPID-RICHCELLS, which is incorporated by reference in its entirety.

Applying the combined modality treatment device 104 with pressure orwith a vacuum type force to the subject's skin or pressing against theskin can be advantageous to achieve efficient treatment. In general, thesubject 101 has a body temperature of about 37° C., and the bloodcirculation is one mechanism for maintaining a constant bodytemperature. As a result, blood flow through the skin and subcutaneouslayer of the region to be treated can be viewed as a heat source thatcounteracts the cooling of the subdermal fat. As such, cooling thetissue of interest requires not only removing the heat from such tissuebut also that of the blood circulating through this tissue. Thus,temporarily reducing or eliminating blood flow through the treatmentregion, by means such as, e.g., applying the treatment device withpressure, can improve the efficiency of tissue cooling and avoidexcessive heat loss through the dermis and epidermis. Additionally, avacuum can pull skin away from the body which can assist in coolingtargeted underlying tissue.

By cooling the subcutaneous tissue to a temperature lower than 37° C.,subcutaneous lipid-rich cells selectively can be damaged. In general,the epidermis and dermis of the subject 101 have lower amounts of lipidscompared to the underlying lipid-rich cells forming the subcutaneoustissues. Because non-lipid-rich cells usually can withstand coldertemperatures better than lipid-rich cells, the subcutaneous lipid-richcells can be selectively injured while maintaining the non-lipid-richcells in the dermis and epidermis. An exemplary range for cooling thelipid-rich cells not warmed or otherwise protected from heat generatedby RF energy-conducting fibrous septae can be from about −10° C. toabout 0° C.

FIG. 4 is a schematic, cross-sectional view illustrating a combinedmodality treatment device 104 for removing heat from bulging orherniating subcutaneous lipid-rich cells at or near thedermis—subcutaneous interface, or from adipose tissue separated orspaced apart from anchoring fibrous septae in the subcutaneous layer.The treatment device 104 can include a heat exchanging unit, such as aheat exchanging plate 210, and an interface layer 220. In oneembodiment, the heat exchanging plate 210 is a thermally conductivealuminum plate that can be charged with RF current generated by the RFenergy generating unit 107 (FIG. 1).

The heat exchanging plate 210 can contain a communication component 215that communicates with the controller 114 to provide a first sensorreading 242 as described herein, and a sensor 217 that measures, e.g.,temperature of the heat exchanging plate 210, heat flux across a surfaceof or plane within the heat exchanging plate 210 or RF current. Theinterface layer 220 can be a plate, a film, a covering, a sleeve orother suitable materials described herein and may serve as the patientprotection device described herein. The interface layer 220 is locatedbetween the heat exchanging plate 210 and the skin 230 of a subject (notshown), such as the skin of a patient receiving treatment via thecombined modality treatment device 104.

The interface layer 220 can also contain a similar communicationcomponent 225 that communicates with the controller 114 to provide asecond sensor reading 244 and a sensor 227 that measures, e.g., thetemperature of the interface layer 220, heat flux across a surface of orplane within the interface layer 220, RF current or contact pressurewith the skin 230 of the patient. For example, one or both of thecommunication components 215, 225 can receive and transmit informationfrom the controller 114, such as temperature and/or heat fluxinformation as determined by one or both of the sensors 217, 227. Thesensors 217, 227 are configured to measure a parameter of the interfacewithout substantially impeding heat transfer between the heat exchangingplate 210 and the subject's skin 230. The treatment device 104 can alsocontain power components and other components described with respect toFIG. 1 and related applications.

In certain embodiments, the combined modality treatment device 104 caninclude a dielectric sleeve 250 for contacting the patient's skin 230and for achieving a more uniform distribution of RF energy into thepatient's underlying subcutaneous tissue. The sleeve 250 can include afirst sleeve portion 252 and a second sleeve portion 254 extending fromthe first sleeve portion. The first sleeve portion 252 can contactand/or facilitate the contact of the combined modality treatment device104 with the patient's skin 230, while the second sleeve portion 254 canbe an isolation layer extending from the first sleeve portion 252. Thesecond sleeve portion 254 can be constructed from latex, rubber, nylon,Kevlar®, or other substantially impermeable or semi-permeable material.The second sleeve portion 254 can prevent contact between the patient'sskin 230 and the heat exchanging plates 210, among other things.

The surface of the first sleeve portion 252 can include a dielectric orvariable resistance material providing an insulator between the RFconductive heat exchanging plate 210 and interface layer 220 and thepatient's skin 230. For example, the material can include materialcoated or comprised of Teflon®, silicon nitride, polysilanes,polysilazanes, polyimides, Kapton and other polymers or dielectricmaterials well known in the art. The capacitive effect of the dielectriclayer (e.g., the first sleeve portion 252) can be controlled, forexample, through sleeve thickness, surface area the dielectric constantof the material and the frequency of the RF energy generated. In someembodiments, the first sleeve portion 252 extends beyond the edges ofthe RF conductive heat exchanging plate 210 and/or other electrodes suchthat the RF current is required to flow through the dielectric materialof the first sleeve portion 252. Further details regarding a suitablesleeve may be found in U.S. Patent Publication No. 2008/0077201.

In other embodiments, the combined modality treatment device 104 caninclude a belt that assists in forming a contact between the treatmentdevice 104 (such as via an interface layer 220) and the patient's skin230. For example, the treatment device 104 can include retention devices(not shown) coupled to a frame. The retention devices may be rotatablyconnected to the frame by a plurality of coupling elements that can be,for example, pins, ball joints, bearings, or other type of rotatablejoints. Alternatively, the retention devices can be rigidly affixed tothe end portions of heat exchanging element housings. Further detailsregarding a suitable belt device may be found in U.S. Patent PublicationNo. 2008/0077211.

In further embodiments, the combined modality treatment device 104 caninclude a vacuum (not shown) that assists in forming a contact betweenthe treatment device 104 (such as via the interface layer 220 ordielectric sleeve 250) and the patient's skin 230. For example, thetreatment device 104 can provide mechanical energy to a treatmentregion. Imparting mechanical vibratory energy to the patient's tissue byrepeatedly applying and releasing a vacuum to the subject's tissue, forinstance, creates a massage action during treatment. Further detailsregarding a vacuum type device may be found in U.S. Patent ApplicationPublication No. 2008/0287839.

In current practice, non-invasive cryotherapy applications used for bodycontouring applications are used to uniformly treat adipose tissue in asubject's target region. In body regions that are characterized bynon-uniform distribution of adipose tissue due to bulging or herniatinglipid-rich lobules at or near the dermis—subcutaneous interface, orother subcutaneous regions lacking sufficient connective tissue, coolingtherapy alone may not result in selective disruption of the adiposetissue responsible for visible irregularities in the surface of the skin(e.g., cellulite). Also in current practice, thermal therapy has beenused to disrupt and alter the three dimensional structure of collagen insubcutaneous tissue by applying thermal energy at frequencies sufficientto heat the fibrous septae to temperatures exceeding a collagendenaturation temperature. However, such thermal therapies do not addressuneven distribution of adipose tissue or penetration of lipid-richlobules into the dermis.

In contrast to the known practices in the art, the systems, devices andmethods disclosed herein facilitate selective disruption of lipid-richlobules in a manner that reduces irregularities in a surface of asubject's skin. For example, the systems, devices and methods disclosedherein use capacitively or conductively coupled RF energy in a manner toprotectively and selectively heat fibrous septae and closely associatedlipid-rich cells (e.g., closely packed adipose tissue) such that theresistively-generated heat in this tissue is sufficient to preventcooling of this tissue to a disruption temperature (e.g., below 10°C.-15° C.). Accordingly the lipid rich lobules at or near thedermis—subcutaneous interface, or other subcutaneous regions lackingsufficient connective tissue, can be selectively disrupted during thetreatment process such that treatment results in consistent andeffective reduction in skin irregularities and cellulite.

C. Combined Modality Treatment Methods

The system 100 can be used to perform several combined modalitytreatment methods. Although specific examples of methods are describedherein, one skilled in the art is capable of identifying other methodsthat the system could perform. Moreover, the methods described hereincan be altered in various ways. As examples, the order of illustratedlogic may be rearranged, sub-stages may be performed in parallel,illustrated logic may be omitted, other logic may be included, etc.

FIG. 5 is a flow diagram illustrating a method 300 for reducingirregularities in a surface of a subject's skin resulting from an unevendistribution of adipose tissue in the subcutaneous layer in accordancewith embodiments of the disclosure. Even though the method 300 isdescribed below with reference to the combined modality treatment system100 of FIG. 1 and the combined modality treatment device 104 of FIG. 4,the method 300 may also be applied in other treatment systems withadditional or different hardware and/or software components.

As shown in FIG. 5, an early stage of the method 300 can includecoupling a heat exchanging surface of a treatment device with thesurface of the subject's skin at a target region (block 302). In oneembodiment, the heat exchanging surface can be a surface of a heatexchanging plate. In another embodiment, the heat exchanging surface canbe the surface of an interface layer or a dielectric layer. Coupling ofthe heat exchange surface to the surface of the skin can be facilitatedby using restraining means, such as a belt or strap. In otherembodiments, a vacuum or suction force can be used to positively couplethe patient's skin at the target region to the heat exchange surface.Additionally, coupling the heat exchanging device to the subject's skincan also include providing a cryoprotectant to the patient's skin as isdescribed in commonly assigned U.S. Patent Publication No. 2007/0255362.

The method 300 can also include delivering radiofrequency (RF) energy tothe target region at a frequency sufficient selectively to heat fibrousseptae in a subcutaneous layer of the target region (block 304). In someembodiments, the RF energy may be monopolar while in other embodimentsit may be bipolar. In some embodiments, the RF energy may becapacitively coupled while in other embodiments it may be conductivelycoupled. In one embodiment, the RF energy can be delivered at afrequency of about 0.3 MHz to about 6 MHz. In other embodiments, the RFenergy can be delivered at a frequency of between about 0.3 MHz to about100 MHz or higher while in still other embodiments such RF energy can bedelivered at a frequency of between about 0.3 MHz to about 40 MHz. Insome embodiments, selective heating of the fibrous septae can includeheating the fibrous septae to a final temperature less than a fibrousseptae denaturation temperature (e.g., about 60° C.). For example,selective heating of the fibrous septae can include heating the fibrousseptae to a temperature that does not denature fibrous septae. Thefibrous septae can provide a path for preferentially conducting RFcurrent through the subcutaneous layer. As the natural resistance offibrous septae to the movement of charged ions and molecules in thesubcutaneous tissue causes the fibrous septae to generate heat. One ofordinary skill in the art will recognize that the RF power (e.g.,measured in watts) delivered to the target region, to achieve a desiredfibrous septae temperature range, will be proportional to the surfacearea of the target region treated among other factors. In some aspects,selectively heating the fibrous septae includes preventing the fibrousseptae and the lipid-rich regions adjacent to the fibrous septae fromcooling to a temperature below approximately 10° C.-15° C.

At block 306, the method 300 includes removing heat such that lipid-richcells in the subcutaneous layer are reduced in number and/or size to anextent while non-lipid-rich cells and lipid-rich regions adjacent to thefibrous septae are not reduced in number or size to the extent. Forexample, removing heat from the subcutaneous layer in the target regioncan include cooling the lipid-rich tissue to a temperature below 10° C.such that the lipid-rich lobules, and the adipose cells are disrupted.

Delivering the RF energy to the target region and removing heat from thesubcutaneous layer in the target region may occur simultaneously. Forexample, the treatment method 300 may include a single stage or multiplestages of delivering RE energy with each such stage occurringsimultaneously with a single stage or multiple stages of removing heatfrom the lipid-rich cells in the target region.

Alternatively, delivering the RF energy to the target region andremoving heat from the subcutaneous layer in the target region may occursequentially. For example, the method 300 may consist of a single stageof delivering RF energy that ceases prior to a single stage to removeheat from the lipid-rich cells in the target region. Additionally, suchsequential application of the aforementioned stages may occur multipletimes so that multiple non-overlapping stages of RF energy delivery andheat removal occur.

Another way that method 300 may be accomplished is by periodically orintermittently delivering RF energy to the target region of the subjectsimultaneously with removing heat. For example, method 300 may comprisea single stage of removing heat from the lipid-rich cells in the targetregion during which stage RF energy is delivered in multiple stages in aregular, periodic fashion or in a less regular, intermittent fashion,

Alternatively, method 300 may include a single stage of delivering RFenergy to the target region during which stage removing heat from thetarget region is accomplished in multiple stages in a regular, periodicfashion or in a less regular, intermittent fashion.

The duration of delivering the RF energy to the target region accordingto the embodiments described herein for reducing irregularities in asurface of skin of a subject resulting from an uneven distribution ofadipose tissue in a subcutaneous layer of that subject, including inaccordance with the method 300, may vary depending on the location ofthe target region, the degree of warming required, the power setting,whether the RF energy is capacitively or conductively coupled, theparameters of the stage of removing heat to reduce the number and/orsize of the lipid-rich cells in the subcutaneous layer, and otherparameters.

Such a duration may be calculated and described in terms of a singleapplication of RF energy or cumulatively as summed over the course ofmore than one application of RF energy. For example, a singleapplication of RF energy as described herein may range in duration froma second or less to several hours or more; e.g., the same or about thesame duration as the duration of the stage of removing heat from thelipid-rich cells in the target region as described for example in U.S.Pat. No. 7,367,341, particularly when the RF energy is appliedcommensurately with the stage of removing heat. A duration of a periodof application of RF energy in such an embodiment may, e.g., be betweenabout 1 minute and about 2 hours, between about 1 minute and about 1hour, between about 1 minute and about 50 minutes, or between about 1minute and about 40 minutes, or between about 1 minute and about 30minutes, or between about 1 minute and about 20 minutes. Still anotherembodiment results in a single application of RF energy of between about5 minutes and about 15 minutes.

Applying RF energy in multiple stages as described herein, whether inperiodic or intermittent fashion, for example, may also rangecumulatively over those multiple stages in duration from a second orless to several hours or more. A cumulative duration of multiple stagesof RF energy application in such embodiments may, e.g., be between about1 minute and about 1 hour, or between about 1 minute and about 50minutes, or between about 1 minute and about 40 minutes, or betweenabout 1 minute and about 30 minutes, or between about 1 minute and about20 minutes. Still another embodiment results in a cumulative duration ofmultiple stages of RF energy application of between about 5 minutes andabout 15 minutes.

D. Suitable Computing Environments

FIG. 6 is a schematic block diagram illustrating subcomponents of acomputing device 400 in accordance with an embodiment of the disclosure.The computing device 400 can include a processor 401, a memory 402(e.g., SRAM, DRAM, flash, or other memory devices), input/output devices403, and/or subsystems and other components 404. The computing device400 can perform any of a wide variety of computing processing, storage,sensing, imaging, and/or other functions. Components of the computingdevice 400 may be housed in a single unit or distributed over multiple,interconnected units (e.g., though a communications network). Thecomponents of the computing device 400 can accordingly include localand/or remote memory storage devices and any of a wide variety ofcomputer-readable media.

As illustrated in FIG. 6, the processor 401 can include a plurality offunctional modules 406, such as software modules, for execution by theprocessor 401. The various implementations of source code (i.e., in aconventional programming language) can be stored on a computer-readablestorage medium or can be embodied on a transmission medium in a carrierwave. The modules 406 of the processor can include an input module 408,a database module 410, a process module 412, an output module 414, and,optionally, a display module 416.

In operation, the input module 408 accepts an operator input 419 via theone or more input devices described above with respect to FIG. 1, andcommunicates the accepted information or selections to other componentsfor further processing. The database module 410 organizes records,including patient records, treatment data sets, treatment profiles andoperating records and other operator activities, and facilitates storingand retrieving of these records to and from a data storage device (e.g.,internal memory 402, an external database, etc.). Any type of databaseorganization can be utilized, including a flat file system, hierarchicaldatabase, relational database, distributed database, etc.

In the illustrated example, the process module 412 can generate controlvariables based on sensor readings 418 from sensors (e.g., thetemperature measurement components 217 and 227 of FIG. 4) and/or otherdata sources, and the output module 414 can communicate operator inputto external computing devices and control variables to the controller114. The display module 416 can be configured to convert and transmitprocessing parameters, sensor readings 418, output signals 320, inputdata, treatment profiles and prescribed operational parameters throughone or more connected display devices, such as a display screen,printer, speaker system, etc. A suitable display module 416 may includea video driver that enables the controller 114 to display the sensorreadings 418 or other status of treatment progression on the outputdevice 120 (FIG. 1).

In various embodiments, the processor 401 can be a standard centralprocessing unit or a secure processor. Secure processors can bespecial-purpose processors (e.g., reduced instruction set processor)that can withstand sophisticated attacks that attempt to extract data orprogramming logic. The secure processors may not have debugging pinsthat enable an external debugger to monitor the secure processor'sexecution or registers. In other embodiments, the system may employ asecure field programmable gate array, a smartcard, or other securedevices.

The memory 402 can be standard memory, secure memory, or a combinationof both memory types. By employing a secure processor and/or securememory, the system can ensure that data and instructions are both highlysecure and sensitive operations such as decryption are shielded fromobservation.

Suitable computing environments and other computing devices and userinterfaces are described in commonly assigned U.S. Provisional PatentApplication Ser. No. 61/100,248, entitled “TREATMENT PLANNING SYSTEMSAND METHODS FOR BODY CONTOURING APPLICATIONS,” filed on Sep. 25, 2008,which is incorporated herein in its entirety by reference.

E. Conclusion

Various embodiments of the technology are described above. It will beappreciated that details set forth above are provided to describe theembodiments in a manner sufficient to enable a person skilled in therelevant art to make and use the disclosed embodiments. Several of thedetails and advantages, however, may not be necessary to practice someembodiments. Additionally, some well-known structures or functions maynot be shown or described in detail, so as to avoid unnecessarilyobscuring the relevant description of the various embodiments. Althoughsome embodiments may be within the scope of the claims, they may not bedescribed in detail with respect to the Figures. Furthermore, features,structures, or characteristics of various embodiments may be combined inany suitable manner. Moreover, one skilled in the art will recognizethat there are a number of other technologies that could be used toperform functions similar to those described above and so the claimsshould not be limited to the devices or routines described herein. Whileprocesses or blocks are presented in a given order, alternativeembodiments may perform routines having stages, or employ systems havingblocks, in a different order, and some processes or blocks may bedeleted, moved, added, subdivided, combined, and/or modified. Each ofthese processes or blocks may be implemented in a variety of differentways. Also, while processes or blocks are at times shown as beingperformed in series, these processes or blocks may instead be performedin parallel, or may be performed at different times. The headingsprovided herein are for convenience only and do not interpret the scopeor meaning of the claims.

The terminology used in the description is intended to be interpreted inits broadest reasonable manner, even though it is being used inconjunction with a detailed description of identified embodiments.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise,” “comprising,” and thelike are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense; that is to say, in a sense of “including,but not limited to.” Words using the singular or plural number alsoinclude the plural or singular number, respectively. When the claims usethe word “or” in reference to a list of two or more items, that wordcovers all of the following interpretations of the word: any of theitems in the list, all of the items in the list, and any combination ofthe items in the list.

Some of the functional units described herein have been labeled asmodules, in order to more particularly emphasize their implementationindependence. For example, modules may be implemented in software forexecution by various types of processors. An identified module ofexecutable code may, for instance, comprise one or more physical orlogical blocks of computer instructions which may, for instance, beorganized as an object, procedure, or function. The identified blocks ofcomputer instructions need not be physically located together, but maycomprise disparate instructions stored in different locations which,when joined logically together, comprise the module and achieve thestated purpose for the module.

A module may also be implemented as a hardware circuit comprising customVLSI circuits or gate arrays, off-the-shelf semiconductors such as logicchips, transistors, or other discrete components. A Module may also beimplemented in programmable hardware devices such as field programmablegate arrays, programmable array logic, programmable logic devices or thelike.

A module of executable code may be a single instruction, or manyinstructions, and may even be distributed over several different codesegments, among different programs, and across several memory devices.Similarly, operational data may be identified and illustrated hereinwithin modules, and may be embodied in any suitable form and organizedwithin any suitable type of data structure. The operational data may becollected as a single data set, or may be distributed over differentlocations including over different storage devices, and may exist, atleast partiaIly, merely as electronic signals on a system or network.

Any patents, applications and other references, including any that maybe listed in accompanying filing papers, are incorporated herein byreference. Aspects of the described technology can be modified, ifnecessary, to employ the systems, functions, and concepts of the variousreferences described above to provide yet further embodiments.

These and other changes can be made in light of the above DetailedDescription. While the above description details certain embodiments anddescribes the best mode contemplated, no matter how detailed, variouschanges can be made. Implementation details may vary considerably, whilestill being encompassed by the technology disclosed herein. As notedabove, particular terminology used when describing certain features oraspects of the technology should not be taken to imply that theterminology is being redefined herein to be restricted to any specificcharacteristics, features, or aspects of the technology with which thatterminology is associated. In general, the terms used in the followingclaims should not be construed to limit the claims to the specificembodiments disclosed in the specification, unless the above DetailedDescription section explicitly defines such terms. Accordingly, theactual scope of the claims encompasses not only the disclosedembodiments, but also all equivalents.

I claim:
 1. A system for non-invasive, transdermal removal of heat fromsubcutaneous lipid-rich cells of a subject, comprising: a treatment unitin thermal communication with a fluid chamber, the fluid chamber beingconfigured to house and provide a coolant; a radiofrequency (RF) energygenerating unit for generating RF current; a treatment device in fluidcommunication with the treatment unit and in electrical communicationwith the RF energy generating unit; and a controller in communicationwith the treatment unit, the RF energy generating unit and the treatmentdevice, wherein the controller has instructions for causing thetreatment device to: couple RF energy to the subject selectively to heatconnective tissue in a target region beneath an epidermis of the subjectto a maximum temperature less than a collagen denaturation temperature;and reduce a temperature of the target region beneath the epidermis ofthe subject selectively to reduce the temperature of subcutaneouslipid-rich cells in the target region such that the subcutaneouslipid-rich cells are substantially affected while non-lipid rich cellsin the epidermis and subcutaneous lipid-rich cells adjacent to theconnective tissue are not substantially affected.
 2. The system of claim1 wherein the treatment device is configured to capacitively couple RFenergy to the subject.
 3. The system of claim 2 wherein the treatmentdevice capacitively couples monopolar RF energy to the subject, andwherein the system further includes a return electrode positionedadjacent to the epidermis of the subject at a region separated from thetarget region.
 4. The system of claim 1 wherein the treatment device isconfigured to conductively couple RF energy to the subject.
 5. Thesystem of claim 1 wherein the collagen denaturation temperature isapproximately 60° C.
 6. The system of claim 1 wherein the connectivetissue is selectively heated to a maximum temperature betweenapproximately 0° C. to approximately 10° C.
 7. The system of claim 1wherein the connective tissue selectively is heated to a maximumtemperature such that subcutaneous lipid-rich cells adjacent to theconnective tissue are not cooled to temperatures below approximately 10°C.-15° C., and such that subcutaneous lipid-rich cells remote from theconnective tissue are cooled to a temperature approximately less than10° C.
 8. The system of claim 1 wherein the radiofrequency (RF) energygenerating unit produces an RF current of approximately 0.3 MHz toapproximately 40 MHz.
 9. The system of claim 1 wherein the controller isconfigured to cause the treatment device to remove heat from the targetregion while delivering the RF energy to the target region.
 10. Thesystem of claim 1 wherein the treatment device is configured to deliverthe RF energy at a frequency of about 0.3 MHz to about 40 MHz.
 11. Thesystem of claim 1 wherein the controller has instructions for causingthe treatment device to deliver the RF energy to the target region whileremoving heat from the target region.
 12. The system of claim 1 whereinthe controller is configured to cause the treatment device tosequentially remove heat from the target region and deliver the RFenergy to the target region.
 13. A combined modality treatment systemfor selectively removing heat from subcutaneous lipid-rich cells in atarget region of a subject having skin, comprising: a treatment unit inthermal communication with a fluid chamber, the fluid chamber beingconfigured to house and provide a coolant; a radiofrequency (RF) energysource for generating RF current; a controller; and a treatment devicehaving a heat exchanging plate coupled to the RF energy source and athermoelectric cooling element in communication with the treatment unit;wherein the controller has instructions that cause the treatment deviceto— capacitively couple radiofrequency (RF) energy to the skin of thesubject selectively to heat fibrous septae in the target region to afinal temperature less than a fibrous septae denaturation temperature;and remove heat from the subcutaneous lipid-rich cells of the subjectduring a treatment process such that subcutaneous lipid-rich cells aresubstantially affected while non-lipid-rich cells and subcutaneouslipid-rich cells adjacent to the fibrous septae are not substantiallyaffected.
 14. The system of claim 13 wherein the heat exchanging plateis a thermally conductive aluminum plate that can be charged with RFcurrent.
 15. The system of claim 13 wherein the treatment device furthercomprises an interface layer positioned between the heat exchangingplate and the skin of the subject, the interface layer configured toform an RF energy and heat conducting interface with the skin.
 16. Thesystem of claim 15 wherein the treatment device further comprises adielectric layer positioned between the heat exchanging plate and theskin of the subject, the dielectric layer configured to capacitivelycouple the RF energy from the heat exchanging plate to the skin of thepatient.
 17. The system of claim 16 wherein the dielectric layerprovides a more uniform distribution of RF energy into the target regionof the subject.
 18. The system of claim 16 wherein the dielectric layeris a dielectric sleeve, the dielectric sleeve including a first sleeveportion and a second sleeve portion extending from the first sleeveportion, the first sleeve portion comprising variable resistancematerial as insulation between the RF conductive heat exchanging plateand the skin of the patient, and wherein the second sleeve portion is anelectrical isolation layer extending from the first sleeve portion. 19.The system of claim 13 wherein the fibrous septae denaturationtemperature is approximately 60° C.
 20. The system of claim 13 whereinthe fibrous septae are selectively heated to a final temperature betweenapproximately 0° C. and approximately 60° C.
 21. The system of claim 13wherein the fibrous septae are selectively heated to a final temperaturesuch that subcutaneous lipid-rich cells adjacent to the fibrous septaeare not cooled to temperatures below approximately 10° C.-15° C., andsuch that subcutaneous lipid-rich cells remote from the fibrous septaeare cooled to a temperature approximately less than 10° C.
 22. Thesystem of claim 13 wherein the treatment device is configured to deliverthe RF energy at a frequency of about 0.3 MHz to about 40 MHz.
 23. Thesystem of claim 13 wherein the controller is configured to receiveinstructions to cause the treatment device to cool the lipid-rich cellsto a temperature below about 10° C.
 24. The system of claim 13 whereinthe controller is configured to cause the cause the treatment device todeliver the RF energy while the treatment device cools the lipid-richcells to a temperature below about 10°.
 25. The system of claim 13wherein the treatment device is configured to deliver ultrasound energy.26. The system of claim 13 wherein the treatment device is configured todeliver microwave energy.
 27. The system of claim 13 wherein thecontroller has instructions for causing the treatment device to deliverthe RF energy to the target region while removing heat from the targetregion.
 28. The system of claim 13, wherein the treatment device isconfigured to deliver the RF energy from the RF energy source to theskin of the subject and to remove heat from the subject via the heatexchanging plate.
 29. The system of claim 13 wherein the treatmentdevice is configured to deliver one or more of optical energy, acousticenergy, and microwave to the subject's skin.
 30. The system of claim 13wherein the controller is configured to sequentially remove heat fromthe target region and deliver the RF energy to the target region.